Af­ter tout­ing Gazy­va's po­ten­tial in lu­pus, Roche nabs 'break­through' ahead of PhI­II

Roche’s ef­fort to in­tro­duce its blood can­cer drug Gazy­va to the im­munol­o­gy space just got a boost from the FDA.

Reg­u­la­tors have grant­ed break­through des­ig­na­tion to the use of the CD20-tar­get­ing an­ti­body in lu­pus nephri­tis, a life-threat­en­ing man­i­fes­ta­tion of sys­temic lu­pus ery­the­mato­sus in the kid­ney. Up to 60% of all peo­ple with lu­pus — dis­pro­por­tion­ate­ly women — de­vel­op such in­flam­ma­tion in the kid­ney, the Lu­pus Foun­da­tion of Amer­i­ca es­ti­mates.

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